Foundation of Regulatory Affairs in a Global Environment
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Overview
Subject area
CTM
Catalog Number
502
Course Title
Foundation of Regulatory Affairs in a Global Environment
Department(s)
Description
This course will provide an overview of the responsibility of the US Food and Drug Administration (FDA) and the International Conference on Harmonization, Good Clinical Practice (ICH GCP) in protecting and promoting public health by regulating the drugs, biologics and medical devices in the US and globally. The course will also describe different Code of Federal Regulations applicable to the clinical trial process.
Typically Offered
Fall, Spring
Academic Career
Graduate
Liberal Arts
No
Credits
Minimum Units
3
Maximum Units
3
Academic Progress Units
3
Repeat For Credit
No
Components
Name
Lecture
Hours
3